NCT02799446Unknown3 期
Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial
Joshua S. Jacobs1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in computed tomography (CT) score
研究概览
简要总结
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Willingness and ability to comply with the requirements of the study
- •Female or male patients ages 18-75 at the time of screening
- •A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
- •Elevated blood eosinophils
- •Significant findings on computed tomography (CT) scan
排除标准
- •Unable to sign informed consent form
- •A woman that is pregnant or nursing a child
- •Known hypersensitivity to Reslizumab
- •Active cigarette smoking in the year prior to screening
- •Known underlying immunodeficiency
- •History of alcohol or drug abuse in the year prior to screening
- •Other criteria may apply. Please contact the investigator for more information
研究组 & 干预措施
Reslizumab
Experimental
Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.
干预措施: Reslizumab (Drug)
Placebo
Placebo Comparator
Matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in computed tomography (CT) score
时间窗: 24 weeks
次要结局
- Quality of life questionnaire(24 weeks)
- Smell test(24 weeks)
- Endoscopy score(24 weeks)
- Adverse events by body system(24 weeks)
研究者
Joshua S. Jacobs
MD
Allergy and Asthma Clinical Research Inc.
研究点 (1)
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